Study Using High-Dose Single Fraction Image-Guided Radiotherapy for Metastatic Lesions to Soft Tissue Masses, Lymph Node, or Bone - Full Text View

Purpose

The purpose of this research study is to find out what IG-IMRT radiation dose works best for treatment of disease in bone or soft tissues. This protocol will study what dose level may work most effectively. The first part of study will treat 10 patients with 22 Gray. Gray (Gy) is the unit that is used to describe the dose of radiation that is being given to a person with cancer. After we confirm that 22 Gy is a safe and sufficient amount of radiation, we will then treat another group of patients with 24 Gy and so on until we reach 28 Gy. Each dose level starting with 24 Gy will enroll at least 20 patients per treatment site (bone, bowel and/or spine). Patients will be enrolled in each treatment category until 20 patients in each strata reach an evaluable time point of 3 months post-RT. When we understand what dose works best and has the least amount of bad effects, the study will then look to see how well the patients do after the radiation therapy. This study is trying to see how your doctor can best treat the cancer that has spread to the other parts of your body.

Condition	Intervention	Phase
Metastatic Disease	Radiation: intensity modulated radiation therapy	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Dose Escalation Study Using High-Dose Single Fraction Image-Guided Radiotherapy for Metastatic Lesions to Soft Tissue Masses, Lymph Node, or Bone

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To assess the feasibility of single dose image-guided intensity modulated radiotherapy (IGIMRT)for metastatic disease to soft tissue, lymph nodes or bones. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To establish the maximal safe single fraction dose for osseous and soft tissue metastatic lesions using IG-IMRT in a Phase I dose escalation study. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
To obtain information on the effect of high-dose external beam irradiation on the biodistribution and pharmacokinetics of FLT. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To obtain preliminary information on the changes in tumor perfusion resulting from high-dose, single fraction IGRT for patients treated with approach to focal metastases using dynamic contrast-enhanced (DCE)-MRI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	290
Study Start Date:	August 2006
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Patients with metastatic disease to soft tissue.	Radiation: intensity modulated radiation therapy Patients will be accrued at each dose level beginning at 22 Gy with increments of 2 Gy up to 28 Gy. Patients with a soft tissue mass, lymph nodes or focal bone metastases with lesions large enough to be imaged on CT scan will be accrued. Starting at 24 Gy, patients will be stratified in to 3 treatment categories: lesions involving bone, bowel, or spinal cord. Patients will be enrolled in each treatment category until 10 patients in that cohort reach an evaluable timepoint of 3 months post-RT. The maximum accrual is 20 for 22 Gy, and 90 (30 per treatment category) for each subsequent dose level (24-28 Gy). Some of these patients have participated in the optional FLT-PET scan portion of the study. Some of these patients have under gone an optional MRI scan which take place within one hour of the radiation treatment .
Experimental: 2 Patients with metastatic disease to lymph nodes.	Radiation: intensity modulated radiation therapy Patients will be accrued at each dose level beginning at 22 Gy with increments of 2 Gy up to 28 Gy. Patients with a soft tissue mass, lymph nodes or focal bone metastases with lesions large enough to be imaged on CT scan will be accrued. Starting at 24 Gy, patients will be stratified in to 3 treatment categories: lesions involving bone, bowel, or spinal cord. Patients will be enrolled in each treatment category until 10 patients in that cohort reach an evaluable timepoint of 3 months post-RT. The maximum accrual is 20 for 22 Gy, and 90 (30 per treatment category) for each subsequent dose level (24-28 Gy). Some of these patients have participated in the optional FLT-PET scan portion of the study. Some of these patients have under gone an optional MRI scan which take place within one hour of the radiation treatment .
Experimental: 3 Patients with metastatic disease to the bone.	Radiation: intensity modulated radiation therapy Patients will be accrued at each dose level beginning at 22 Gy with increments of 2 Gy up to 28 Gy. Patients with a soft tissue mass, lymph nodes or focal bone metastases with lesions large enough to be imaged on CT scan will be accrued. Starting at 24 Gy, patients will be stratified in to 3 treatment categories: lesions involving bone, bowel, or spinal cord. Patients will be enrolled in each treatment category until 10 patients in that cohort reach an evaluable timepoint of 3 months post-RT. The maximum accrual is 20 for 22 Gy, and 90 (30 per treatment category) for each subsequent dose level (24-28 Gy). Some of these patients have participated in the optional FLT-PET scan portion of the study. Some of these patients have under gone an optional MRI scan which take place within one hour of the radiation treatment .

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Biopsy-proven cancer verified at MSKCC
Imaging evidence of lymph node metastases, bone metastases or soft tissue disease
Age > or = to 18 years
KPS > or = to 80
Epidural disease is acceptable as long as the dose to the spinal cord ≤ 14 Gy
Able to tolerate immobilization cradle positioning

Exclusion Criteria:

Target lesion not visible on conventional CT scan
Unable to be administered intravenous CT contrast safely
Prior radiation to the planned target region. A second metastatic lesion would not be eligible if the area received or will receive any dose (5% or greater isodose line)from a prior or planned single fraction treatment
Patients receiving concurrent chemotherapy (within 1 week of RT)
Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to 15-16 Gy dose constraints
Weight-bearing bones with significant cortical destruction from tumor. In these cases, patients will be referred for orthopedic consultation for rod stabilization procedures.
Subjects with more than 4 metastases to bone
Any metastatic lesion larger than 8 cm in its greatest diameter

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678158

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Michael Zelefsky, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00678158 History of Changes
Other Study ID Numbers:	06-101
Study First Received:	May 13, 2008
Last Updated:	October 10, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

High Does Single Fraction IGRT
Bone
Lymph Nodes
Soft Tissue

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013